Tachyphylaxis

Vyluma Announces Positive Results From Second Stage of Phase III CHAMP Study of NVK002 for the Treatment of Myopia in Children

Retrieved on: 
Wednesday, October 11, 2023
Incidence, Tachyphylaxis, Food, CHAMP, Trial of the century, New Drug Application, Safety, Near-sightedness, FDA, NDA, Approximation error, TAES, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SER, PDUFA, Patient, Pharmaceutical industry

During the fourth year of the study, both doses of NVK002 -- the 0.01% and 0.02% concentrations -- continued to exhibit a strong safety profile with a low level (8% incidence) of Treatment Emergent Adverse Events (TAES) and no evidence of meaningful rebound in subjects who had discontinued active treatment and were washed out over one year. In year four, NVK002 0.01% data indicate a continued widening of the previously reported treatment effect1 in both the mean change from baseline in Spherical Equivalent Refraction (SER), and mean change from baseline in axial length endpoints when compared to a matched historical placebo group. There was no evidence of tachyphylaxis in the treatment effect after four years.

Key Points: 
  • Analysis of the results of this multi-center, international study conducted after four years of treatment and follow up, show continued strong safety, the absence of rebound upon washout of the study drug, and continued efficacy for NVK002 as a potential treatment for myopia in children.
  • “With the completion of the second and final phase of CHAMP, Vyluma continues its progress towards bringing NVK002 forward as an important new, first-in-class pharmaceutical treatment option for children with myopia.
  • The NDA for NVK002 is currently under review with the FDA, and a decision is expected in January 2024,” stated Founder & Chairman, Navneet Puri PhD.
  • In June 2023 Vyluma announced that the U.S. Food and Drug Administration (FDA) had accepted for review the New Drug Application (NDA) for NVK002.

Dermavant Completes Enrollment of Two Phase 3 Clinical Trials of VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children as Young as 2 years old

Retrieved on: 
Monday, February 13, 2023
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, FDA, Clinical Trials, Therapy, Atopic dermatitis, BSA, Growth, AD, Tachyphylaxis, Psoriasis, Body surface area, Plaque, Patient, Pharmaceutical industry

VTAMA cream is a novel, aryl hydrocarbon receptor agonist, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of AD.

Key Points: 
  • VTAMA cream is a novel, aryl hydrocarbon receptor agonist, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of AD.
  • Dermavant is developing VTAMA cream for atopic dermatitis using the same dose and regimen already FDA-approved for plaque psoriasis.
  • On May 24, 2022, Dermavant announced that the FDA had approved VTAMA (tapinarof) cream, 1% for the treatment of adult plaque psoriasis.
  • As of July 15,2022, VTAMA cream is the #1 prescribed branded topical treatment for plaque psoriasis.i

Arcutis Presents New Phase 2 Long-Term Data Showing Sustained Efficacy and Clearance for a Median of 10 Months with Roflumilast Cream in Adults with Chronic Plaque Psoriasis

Retrieved on: 
Saturday, January 14, 2023
Kimberley, FAAD, Common, URTI, IGA, Therapy, Icahn School of Medicine at Mount Sinai, Safety, Sinusitis, PDE4, MD, FDA, Irritation, Psoriasis, Urinary tract infection, Patient, Tachyphylaxis, AES, US Foods, Doctor of Philosophy, Mount Sinai, Cosmetics, Pharmaceutical industry, Dermatology

Roflumilast cream 0.3% (ZORYVE®) is a once-daily steroid free topical phosphodiesterase-4 (PDE4) inhibitor approved by the US Food and Drug Administration in July 2022.

Key Points: 
  • Roflumilast cream 0.3% (ZORYVE®) is a once-daily steroid free topical phosphodiesterase-4 (PDE4) inhibitor approved by the US Food and Drug Administration in July 2022.
  • Roflumilast cream was safe and very well tolerated, with the majority of adverse events (AEs) mild-to-moderate in severity.
  • Additional key findings following 52 weeks of treatment with roflumilast cream 0.3% include:
    IGA success was achieved by 35.3% of participants previously treated with roflumilast cream and 37.5% of roflumilast-naïve participants.
  • 1Cohort 1 not shown because I-IGA added as study amendment and numbers of patients evaluated are very small at each timepoint.

Dermavant Announces Highly Favorable Results from Pediatric Maximal Usage Study of VTAMA® (tapinarof) cream, 1% in Atopic Dermatitis

Retrieved on: 
Tuesday, November 8, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Cream, People, Shanda, AES, Face, Sleep, Neck, Atopic dermatitis, JD, NPA, Ageing, IGA, FDA, Patient, Swelling, Calendar, Population, Stinger, QD, Itchy, Disease, Irritation, Headache, Nose, Inflammation, Dermatitis, Pain, Aryl hydrocarbon receptor, Roivant Sciences, Folliculitis, Incidence, PK, Body surface area, Psoriasis, Itch, Fatigue, Gesellschaft mit beschränkter Haftung, Rash, Efficiency, Common, Marketing, Research, Skin, BSA, Therapy, Safety, Pharmacokinetics, Tachyphylaxis, Adult, Cosmetics, Vaccine, Pharmaceutical industry, MD

The studys objective was to characterize the pharmacokinetics (PK) and safety of VTAMA cream under maximal usage conditions in pediatric subjects with atopic dermatitis.

Key Points: 
  • The studys objective was to characterize the pharmacokinetics (PK) and safety of VTAMA cream under maximal usage conditions in pediatric subjects with atopic dermatitis.
  • The maximal usage study of VTAMA cream, 1% utilized the same dose and frequency (1% cream, applied QD) as is being studied in Dermavants ongoing ADORING 1 and ADORING 2 pivotal trials for atopic dermatitis.
  • VTAMA cream, 1% demonstrated favorable safety, PK and clinical improvement in atopic dermatitis in subjects down to 2 years of age.
  • Dermavant anticipates presenting the full data set from its maximal usage study of VTAMA cream, 1% in atopic dermatitis at a future medical meeting.

Engrail Therapeutics Announces Positive Results of ENX-101 Phase 1b Clinical Study and Prepares for Initiation of ENACT Phase 2 Trial in Focal Epilepsy

Retrieved on: 
Tuesday, June 7, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, NYU Langone Health, Tachyphylaxis, Benzodiazepine, Biomarker, PAMS, US, Company, Vital signs, Epilepsy, Conference, Anxiety, PAM, Seizure, Engrailed (gene), Central nervous system, GABAergic, Disease, Half-life, Pain, Solution, Pharmacology, Patient, Somnolence, Restless, Acquisition, Safety, NYU, Clinical trial, Nervous system, GABA-A, ECG, Neurology, Quantitative electroencephalography, Baseline, Pharmaceutical industry, Vaccine, Health insurance

Engrail Therapeutics (Engrail) (the Company), a precision neuroscience company focused on the acquisition, development, and commercialization of transformational therapies, has announced positive results from a phase 1b clinical trial of ENX-101, a subtype-selective GABA-A positive allosteric modulator (PAM).

Key Points: 
  • Engrail Therapeutics (Engrail) (the Company), a precision neuroscience company focused on the acquisition, development, and commercialization of transformational therapies, has announced positive results from a phase 1b clinical trial of ENX-101, a subtype-selective GABA-A positive allosteric modulator (PAM).
  • The phase 1b clinical trial data were presented on June 6, 2022, at the 2022 Epilepsy Pipeline Conference in Santa Clara, California.
  • Following these results and recent interaction with the US FDA that included alignment on the phase 2 development program, Engrail plans to initiate the ENACT Trial, an international multi-center phase 2 clinical trial to evaluate the efficacy and safety of ENX-101 in patients with focal epilepsy.
  • There were no dose-related, clinically meaningful changes in vital signs, electrocardiograms, physical exams, or clinical laboratory values.

Dermavant Showcases New Long-Term Durability and Tolerability Data from Phase 3 PSOARING 3 Trial of Tapinarof Cream for Adults with Plaque Psoriasis at the 2022 AAD Annual Meeting

Retrieved on: 
Friday, March 25, 2022
People, Risk, Adult, PGA, Research, Ageing, JD, Psoriasis, Twitter, Inflammatory bowel disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GLOBE, BSA, Efficiency, Acne, Obesity, QD, DLQI, USC, Hypertension, Quality of life, Global Assessment of Functioning, Keck School of Medicine of USC, Medicine, Plaque, Therapy, Roivant Sciences, AAD, Vitiligo, Irritation, Tachyphylaxis, Diabetes, American Academy, FDA, Atopic dermatitis, Patient, LinkedIn, Skin, Food, Aryl hydrocarbon receptor, PASI, Week, Safety, Dean (education), Dermatology Life Quality Index, Psoriasis Area and Severity Index, Depression, Pharmaceutical industry, MD, Dermatology

The durable improvements demonstrated by tapinarof in PSOARING 3 across efficacy outcomes, quality of life and tolerability scores are encouraging.

Key Points: 
  • The durable improvements demonstrated by tapinarof in PSOARING 3 across efficacy outcomes, quality of life and tolerability scores are encouraging.
  • As a clinician, I am excited about the possibility of a potential new therapy in tapinarof for patients suffering from plaque psoriasis.
  • Eligible patients who completed either PSOARING 1 or 2, which were 12-week pivotal studies of tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis.

Eton Pharmaceuticals and XGen Pharmaceuticals DJB Announce Commercial Launch of Rezipres® (ephedrine hydrochloride), a Ready-to-Use Formulation of Injectable Ephedrine (4.7 mg/mL)

Retrieved on: 
Monday, March 14, 2022
Hypertension, AmerisourceBergen, U.S. Securities and Exchange Commission, Therapy, Atropine, Degenerative disease, Private Securities Litigation Reform Act, Injection, Bradycardia, Bromide, Nervous, Oxytocin, Stroke, Growth, National, Intubation, New Drug Application, Carglumic acid, Safety, McKesson Corporation, Restless, Theophylline, FDA, Anesthesia, Tachyphylaxis, Temperature, Dizziness, Cardinal Health, MAOI, GLOBE, Nausea, Patient, Quinidine, Arrhythmia, Digitalis, Clonidine, XGen Studios, CEO, Ephedrine, Insomnia, Reserpine, Vomiting, Security (finance), Xanthine oxidase inhibitor, Ownership, Hypotension, Sulfite, Nasdaq, Incidence, Mephentermine, Guanethidine, Palpitations, Hospital, Tachycardia, Plasma protein binding, IQVIA, Goal, Pharmaceutical industry

DEER PARK, Ill., March 14, 2022 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON) and XGen Pharmaceuticals DJB, Inc. today announced the commercial availability of Rezipres (ephedrine hydrochloride) injection.

Key Points: 
  • DEER PARK, Ill., March 14, 2022 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON) and XGen Pharmaceuticals DJB, Inc. today announced the commercial availability of Rezipres (ephedrine hydrochloride) injection.
  • Rezipres (4.7 mg/mL) is a ready-to-use1 formulation of injectable ephedrine hydrochloride that is approved for the treatment of clinically important hypotension occurring in the setting of anesthesia.
  • We look forward to partnering with XGen DJB given their extensive track record of successfully commercializing injectable products in the hospital setting, said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
  • We are delighted to be teaming up with Eton as the commercial partner in introducing their ready-to-use Rezipres product, which is the first FDA-approved hydrochloride-based ephedrine injectable formulation, added Edmund Vanderbeck, President of XGen Pharmaceuticals DJB.

Dermavant Showcases New Long-Term Data from Phase 3 PSOARING 3 Trial of Tapinarof in Patients with Plaque Psoriasis at the 30th EADV Virtual Congress

Retrieved on: 
Thursday, September 30, 2021
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Linda, People, Food, Journal of the European Academy of Dermatology and Venereology, Week, Henry Ford, Efficiency, Dermatologic Clinics, Skin, Patient, NDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Plaque, Depression, FDA, QD, PGA, Henry Ford Health System, Adult, Hypertension, Vitiligo, Drug discovery, LinkedIn, Diabetes, Twitter, Remittance, Roivant Sciences, Psoriasis, Ageing, Acne, New Drug Application, Risk, Atopic dermatitis, Tachyphylaxis, Research, Maintenance, Obesity, Inflammatory bowel disease, Safety, Quality of life, Doctor of Philosophy, Global Assessment of Functioning, Yale School of Medicine, Pharmaceutical industry, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant, DERMAVANT’S PHASE 3 PROGRAM FOR TAPINAROF IN PSORIASIS, PSORIASIS, DERMAVANT

The data were presented during a Late-Breaking Session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.

Key Points: 
  • The data were presented during a Late-Breaking Session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.
  • Subjects who received tapinarof treatment during PSOARING 1 or 2 and completed PSOARING 3 received treatment for up to 52 weeks.
  • Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis, and has initiated a Phase 3 program in atopic dermatitis in patients aged 2 years and older.

Nexus Pharmaceuticals Receives Patent for EMERPHED® Ready-To-Use Ephedrine Sulfate Injection

Retrieved on: 
Tuesday, August 17, 2021
FDA, Pharmaceutical, Health, Clinical Trials, Nexus, Journal, Anesthesia, Blood pressure, Technology, Vomiting, Medical college, Sulfate, Trial of the century, Tachycardia, MCW, Nausea, Patent, Drug, Multimedia, Medication, Risk, Hypotension, FDA, Tachyphylaxis, Pharmacy, Medical College of Wisconsin, USPTO, Pharmaceutical industry, EMERPHED® Ready-To-Use Ephedrine Sulfate Injection, Nexus Pharmaceuticals, Inc., EMERPHED® READY-TO-USE EPHEDRINE SULFATE INJECTION, NEXUS PHARMACEUTICALS, INC.

Nexus Pharmaceuticals, Inc., a U.S.-based healthcare company and domestic pharmaceutical manufacturer, has received a patent covering applications of EMERPHED Ready-To-Use Ephedrine Sulfate Injection, the first FDA-approved premixed ephedrine in a ready-to-use 50 mg/10 mL vial.

Key Points: 
  • Nexus Pharmaceuticals, Inc., a U.S.-based healthcare company and domestic pharmaceutical manufacturer, has received a patent covering applications of EMERPHED Ready-To-Use Ephedrine Sulfate Injection, the first FDA-approved premixed ephedrine in a ready-to-use 50 mg/10 mL vial.
  • The United States Patent and Trademark Office (USPTO) issued the patent, U.S. Patent No.
  • View the full release here: https://www.businesswire.com/news/home/20210817005708/en/
    EMERPHED Ready-To-Use Ephedrine Sulfate Injection, the first FDA-approved premixed ephedrine, was launched by Nexus Pharmaceuticals in 2020.
  • (Photo: Business Wire)
    We are very proud of the intellectual property that was created during the development of EMERPHED, said Shahid Ahmed, Chief Scientific Officer of Nexus Pharmaceuticals.